Author: scottmoore1

Federal Court Enjoins the CMS Mandatory Vaccine Emergency Temporary Standard (ETS)

On Monday, November 29, 2021, the United States District Court for the Eastern District of Missouri – Eastern Division has issued a preliminary injunction staying the Centers for Medicare and Medicaid Services (CMS) Mandatory Vaccination Emergency Temporary Standards (ETS) which were set to take effect on January 4, 2022. This preliminary injunction currently only applies to healthcare providers in the plaintiff states.

On November 10, 2021, the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire filed a nine (9) count complaint in the United States Court for the Eastern District of Missouri seeking relief from the CMS Emergency Temporary Standard (ETS) which requires certain certified healthcare facilities to mandate COVID-19 vaccination of all employees, contractors, and those performing services “under arrangement.”  The complaint alleged that the ETS violates numerous provisions of the Administrative Procedures Act (APA), the Social Security Act (SSA), that CMS failed to consult with the state agencies that would be charged with enforcing such a mandate, failure to perform an impact analysis of the new rules, and several other Constitutional violations.

In the ruling, U.S. District Judge Matthew T. Schelp, agreed with the plaintiffs that a preliminary injunction was warranted because it posed an irreparable harm and that the plaintiffs demonstrated a likelihood of success on the merits of their complaint. The thirty-two (32) page ruling cites that Congress did not give CMS the authority to enact the mandatory vaccination regulations, nor authorized CMS to issue regulations that pre-empt validly enacted state legislation that contradict these new rules. The court believed that the plaintiffs would likely be able to show that CMS violated numerous administrative and rulemaking procedures.

Throughout the ruling the court cited the likelihood of significant harm to state sovereignty and how the implementation of the rule’s requirements would cause substantial economic harm to both the states and the healthcare facilities. Not only through the cost of implementation but also through the impact to a healthcare facility’s ability to provide care due to employees who refuse to get vaccinated.

This ruling is only applicable to covered healthcare facilities in the states of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire. It is unknown if the stay will be expanded to other jurisdictions. Additionally, the OSHA Vaccination & Testing ETS is currently enjoined and OHSA has announced that they will halt implementation and enforcement associated with those rules. Despite these rulings, many EMS employers are subject to the mandatory vaccination requirements under the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors.

I advise employers to take the initial steps toward compliance while these cases proceed through the legal system. EMS employers are already required to have policies and procedures to determine and maintain a log of their employee’s vaccination status. Additionally, many EMS employers have already been contacted by their contracted healthcare facilities who have enacted a vaccine mandate, either prior to, or in response to the CMS ETS.  These facilities may still independently require your staff to be vaccinated.

I recognize that these are incredibly challenging times. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing hello@ambulance.org.

 

Federal Government Releases COVID-19 Vaccination Requirement Rules: CMS and OSHA Outline Requirements for Certain Health Care Providers and Certain Employers

by Scott Moore, J.D. & Kathy Lester, J.D. M.P.H.

Today, the Occupational Health and Safety Administration (OSHA) and Centers for Medicare & Medicaid Services (CMS), released the highly anticipated mandatory COVID-19 vaccination regulations for employers with 100 or more employees and new COVID-19 vaccination requirements in the Conditions of Participation (COPs)/Conditions for Coverage (CfCs).

OSHA COVID-19 Vaccination Regulations

A summary of the new rules can be found on the OSHA website.  Under this latest rule, OSHA stated that any employer who is subject to the Healthcare ETS released in June, 2021 is not subject to the Vaccination and Testing ETS.  This would include many EMS employers.  However, healthcare employers should refer to the Healthcare ETS to ensure that they are in compliance with those requirements.

It is important for EMS employers to note, where they have “healthcare support services”, as defined under §1910.502(vi) of the Healthcare ETS, that are not subject to the Healthcare ETS because these employees are segregated in non-healthcare settings (stand-alone administrative facilities), those employees will be subject to the requirements Vaccination and Testing ETS.

There was nothing in the latest ETS that prevents employers from instituting a mandatory vaccination requirement for its employees.  Many EMS employers are already required to mandate vaccination under a state or local law.  These employers may continue to require vaccinations for its employees.

CMS COVID-19 Health Staff Vaccination Rule

CMS also released an Interim Final Rule with Comment (IFC) governing health care staff vaccination requirements, as well as a Press Release, Fact Sheet, and Frequently Asked Questions.  While the IFC regulations do not directly apply to ground ambulance suppliers, the definition of staff that includes individuals contracted with or that have other arrangements with facilities directly regulated will be indirectly subject to the rules through their arrangements with the facilities.  For example, an EMS service that has no contract or arrangement with any of the directly covered health care facilities listed below should not be subject to the CMS requirements.  However, a ground ambulance service that has a contract with a nursing home to provide interfacility transports, for example, would be indirectly affected because of the requirement on the nursing home to ensure that contractors meet the vaccine requirements.  Additionally, there the regulations do not prevented a health care facility from creating their own requirements on vendors that do not have an existing contract with the facility.

The ICF amends the existing Conditions or Participation / Conditions for Coverage for the following facilities:

  • Ambulatory Surgery Centers;
  • Community Mental Health Centers;
  • Comprehensive Outpatient Rehabilitation Facilities;
  • Critical Access Hospitals;
  • End-Stage Renal Disease Facilities;
  • Home Health Agencies;
  • Home Infusion Therapy Suppliers;
  • Hospices;
  • Hospitals;
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services;
  • Psychiatric Residential Treatment Facilities (PRTFs);
  • Programs for All-Inclusive Care for the Elderly Organizations (PACE);
  • Rural Health Clinics/Federally Qualified Health Centers; and
  • Long Term Care facilities.

The IFC requires facilities to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19.  Exclusions from the requirement are permitted for staff (or contactors) who have pending requests for, or who have been granted, exceptions to the vaccine requirements or those staff for whom COVID-19 vaccinations must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

Staff is defined to include employees, as well as licensed practitioners, students, trainees, volunteers, and “[i]ndividuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.”

The IFC excludes (1) staff that exclusively provide telehealth/telemedicine services outside of the facility setting and that do not have direct contact with patients and (2) staff that provide support services exclusively outside of the facility setting and that do not have direct contact with patients.

The IFC defines an individual as fully vaccinated when 2 weeks or more has passed since the staff completed a primary vaccination series for COVID-19.  That can be either the administration of a single-dose vaccine or the administration of all required doses of a multi-dose vaccine.  It does not include booster shots.

Facilities directly regulated by the COPs/CfCs will have to have policies and procedures to implement the requirement.  Among these requirements is a process for ensuring the implementation of additional precautions, intended to mitigate transmission and spread of COVD-19, for all staff (and contractors) who are not fully vaccinated.  There are also contingency planning requirements and documentation and tracking requirements.

The IFC provides facilities 30 days to make sure that staff have received at least the first dose of a primary series or a single dose of COVID-19 vaccine prior the staff providing any care, treatment, or other services for the facility and/or its patients.  Within 60 days, the facility must ensure that staff have completed the primary vaccination services (except for those who have been granted an exemption or exclusion).

CMS will enforce the regulations through the existing onsite compliance review process with state survey agencies. Accreditation organizations will also be required to update their survey processes.  If a facility is not in compliance, the existing enforcement remedies related to the COPs/CfCs, which can include termination from the Medicare program, will apply.

The rule preempts state law under Article VI § 2 of the U.S. Constitution.

The rule takes effect November 5, but stakeholders have 60 days to provide comments with comments due by January 4, 2022.

 

             

 

OCR Issues Guidance on HIPAA, COVID-19 Vaccinations, and the Workplace

Today, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued guidance to help the public understand when the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule applies to disclosures and requests for information about whether a person has received a COVID-19 vaccine.

In the guidance, OCR reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records. The HIPAA Privacy Rule only applies to HIPAA covered entities (health plans, health care clearinghouses, and health care providers that conduct standard electronic transactions), and, in some cases, to their business associates.  The HIPAA Privacy Rule applies to most EMS providers but only as it relates to it’s patient’s Protect Health Information (PHI).

Today’s guidance addresses common workplace scenarios and answers questions about whether and how the HIPAA Privacy Rule applies. The Privacy Rule does not apply when an individual:

  • Is asked about their vaccination status by a school, employer, store, restaurant, entertainment venue, or another individual.
  • Asks another individual, their doctor, or a service provider whether they are vaccinated.
  • Asks a company, such as a home health agency, whether its workforce members are vaccinated.

Generally, the Privacy Rule does not regulate what information can be requested from employees as part of the terms and conditions of employment that an employer may impose on its workforce

The Privacy Rule does not prohibit a covered entity or business associate from requiring or requesting each workforce member to:

  • Provide documentation of their COVID-19 or flu vaccination to their current or prospective employer.
  • Sign a HIPAA authorization for a covered health care provider to disclose the workforce member’s COVID-19 or other vaccination record to their employer.
  • Wear a mask–while in the employer’s facility, on the employer’s property, or in the normal course of performing their duties at another location.
  • Disclose whether they have received a COVID-19 vaccine in response to queries from current or prospective patients.

OCR stated that they are issuing this guidance to help consumers, businesses, and health care entities understand when HIPAA applies to disclosures about COVID-19 vaccination status and to ensure that they have the information they need to make informed decisions about protecting themselves and others from COVID-19.

More details about the latest guidance on HIPAA, COVID-19 Vaccinations, and the Workplace may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-covid-19-vaccination-workplace/index.html.  If you have questions regarding what information you may or may not share relative to COVID-19 vaccinations, please contact the AAA for assistance.

 

New Guidance on COVID-19 Workplace Safety for Federal Contractors

This week, the Safer Federal Workforce Task Force released new guidance on COVID-19 workplace safety protocols for Federal contractors and subcontractors.  On September 9, President Biden signed Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, which directed executive departments and agencies to ensure that all federal contractors and subcontractors comply with all guidance published by the Task Force. These workplace safety protocols will apply to all covered contractor and subcontractor employees in covered contractor workplaces even if they are not working on Federal Government contracts.

Overview of Workplace Safety Protocols for Federal Contractors and Subcontractors

Pursuant to the guidance issued this week, and in addition to any requirements or workplace safety protocols that are applicable because a contractor or subcontractor employee is present at a Federal workplace, Federal contractors and subcontractors with a covered contract will be required to conform to the following workplace safety protocols:

  1. COVID-19 vaccination of covered contractor employees, except in limited circumstances where an employee is legally entitled to a medical or religious accommodation;
  2. Compliance by individuals, including covered contractor employees and visitors, with the Guidance related to masking and physical distancing while in covered contractor workplaces; and
  3. Designation by covered contractors of a person or persons to coordinate COVID-19 workplace safety efforts at covered contractor workplaces.

The guidance provides details regarding who is included under these new rules.  Under the latest guidance, a “Covered Contractor Employee” means any full-time or part-time employee of a covered contractor” working on” or “in connection with” a covered contract or working at a covered contractor workplace. This includes employees of covered contractors who are not themselves working on or in connection with a covered contract, except for those employees who only perform work outside the United States or its outlying areas.  This means that all ambulance service employees, who perform work related to or in connection with the contract, such as dispatchers, human resource and billing personnel, training staff, etc. are subject to the new requirements.  This includes employees working from remotely or from home, who are performing work in connection with the contract.

Under the guidance, a “Covered Contractor Workplaces” are locations controlled by a covered contractor at which any employee of a covered contractor working on or in connection with a covered contract is likely to be present during the period of performance for a covered contract.  This includes those workplaces such as ambulance stations, administrative offices, etc.

Vaccination of Covered Contractor Employees

Covered contractors must ensure that all their covered employees are fully vaccinated for COVID-19 unless the employee is legally entitled to an accommodation. Covered contractor employees must be fully vaccinated no later than December 8, 2021.  The guidance detailed that vaccination is required of all employees, even if they have previously been infected with COVID-19.

Proof of COVID-19 Vaccination

Under this guidance, the contractor or subcontractor must review the covered employee’s documentation to prove vaccination status.  The guidance identifies the list of acceptable documents an employee can furnish to prove vaccination, including:

  1. Copy of Immunization Record from a healthcare provider or pharmacy
  2. Copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published 9/3/2020)
  3. Copy of Medical Records documenting the vaccination
  4. Copy of Immunization Records from a public health or State Immunization Information System
  5. Copy of any other official documentation verifying vaccination with information of:
    1. Vaccine name
    2. Date of administration
    3. Name of healthcare professional or clinic site administering the vaccine

*Digital copies of these records are acceptable (jpg, scanned PDF, etc.)

The guidance specified that a signed attestation by the employee is not acceptable proof of vaccination.  Additionally, the guidance stated that recent COVID-19 antibody tests do not satisfy the requirements under these rules.

Masking and Physical Distancing While in Covered Contractor Workplaces

Covered contractors must ensure that all individuals, including covered contractor employees and visitors, comply with published CDC guidance for masking and physical distancing at a covered contractor workplace. The guidance provided more details on these masking and physical distancing requirements.  These include requiring unvaccinated individuals to mask indoors and in certain outdoor settings regardless of COVID-19 transmission levels.  Contractors are required to monitor the community transmission levels on the CDC COVID-19 Data Tracker County View website on a weekly basis.

COVID-19 Coordinator Designation

Covered contractors must designate a person or persons to coordinate implementation of, and compliance with, these workplace safety protocols at covered contractor workplaces. Their responsibilities to coordinate COVID-19 workplace safety protocols may comprise some or all of their regular duties.  This individual can be the same person who is designated under other state or local COVID-19 safety requirements.

Finally

The guidance makes it clear that the rules applicable to all federal contractors and supersedes any state or local rules or regulations that are contrary to these provisions.  That means that any rules that prohibit mask or other COVID-19 related safety mandates, or otherwise contradict the rules under this guidance will not excuse a federal contractor’s obligations under these rules.

The guidance will be finalized by the Office of Management & Budget in the coming days.  In the meantime, if you have any questions or need assistance, contact the AAA at hello@ambulance.org.

HHS PRF Tranche 4 | Important Funding Opportunity for EMS Providers


Speaker: Scott Moore, Esq. | Share on Facebook
This funding opportunity will distribute $25.5 billion in additional Phase 4 General Distribution for EMS agencies and American Rescue Plan (ARP) payments for qualified rural providers who furnish services to Medicaid/CHIP and Medicare beneficiaries. It is critical for all #EMS providers to apply for this funding opportunity regardless of previous funding allocations. We have learned that many EMS providers did not apply for the Tranche 3 funding opportunity because they did not believe that they would be eligible to receive funds under the announced funding formula. Due to the limited number of applicants in Tranche 3, HRSA modified the formula and many who failed to apply would have received funds. We are recommending that all EMS agencies apply to receive the funding that they desperately need. The deadline for applying is 11:59 p.m. on October 26, 2021. There is no penalty for applying.

HHS: Availability of Add’l $25.5 Billion in COVID-19 Provider Funding

HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding

This morning the Department of Health and Human Services (HHS) announced that it will be making $25.5 billion in new funding available for healthcare providers affected by the COVID-19 pandemic. The funding, available through the Health Resources and Services Administration (HRSA) will include $8.5 billion in American Rescue Plan Act (ARPA) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.

Getting additional financial relief for ground ambulance service providers who are still struggling from the lost revenue and increased expenditures resulting from being on the frontlines of responding to the pandemic has been a top priority for the AAA. The AAA along with the International Association of Fire Chiefs, International Association of Firefighters, National Associations of EMTs and National Volunteer Fire Association have continually pressed HHS to release the remaining funds. We strongly encourage all AAA members to submit an application regardless of whether you have applied for previous rounds of funding.

Consistent with the requirements included in the Coronavirus Response and Relief Supplemental Appropriations Act of 2020, PRF Phase 4 payments will be based on providers’ lost revenues and expenditures between July 1, 2020, and March 31, 2021 (Q3 – Q4 2020 and Q1 2021). The PRF Phase 4 will reimburse smaller providers, who tend to operate on thin margins and often serve vulnerable or isolated communities, for their lost revenues and COVID-19 expenses at a higher rate compared to larger providers. PRF Phase 4 will also include bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients, who tend to be lower- income and have greater and more complex medical needs. HRSA will price these bonus payments at the generally higher Medicare rates to ensure equity for those serving low-income children, pregnant women, people with disabilities, and seniors.

Consistent with the focus of the ARPA, HRSA will make ARPA rural payments to providers based on the amount of Medicaid, CHIP, and/or Medicare services they provide to patients who live in rural areas as defined by the HHS Federal Office of Rural Health Policy. As rural providers serve a disproportionate number of Medicaid and CHIP patients who often have disproportionately greater and more complex medical needs, many rural communities have been hit particularly hard by the pandemic. Accordingly, ARP rural payments will also generally be based on Medicare reimbursement rates.

In the announcement, HHS stated that it would “expedite and streamline” the application process and minimize administrative burdens, providers will apply for both programs in a single application. HRSA will use existing Medicaid, CHIP and Medicare claims data in calculating payments. The application portal will open on September 29, 2021. HHS has stated that to ensure that these provider relief funds are used for patient care, PRF recipients will be required to notify the HHS Secretary of any merger with, or acquisition of, another health care provider during the period in which they can use the payments. They have stated that providers who report a merger or acquisition may be more likely to be audited to confirm their funds were used for coronavirus-related costs.

To promote transparency in the PRF program, HHS also released detailed information about the methodology utilized to calculate PRF Phase 3 payments. Providers who believe their PRF Phase 3 payment was not calculated correctly according to this methodology will now have an opportunity to request a reconsideration. HHS announced that additional details on the PRF Phase 3 reconsideration process will be released at a later date.

In addition, many of you attended the PRF Reporting Q&A AAA webinar yesterday with Asbel Montes, Brian Werfel, and Scott Moore.  HHS has acknowledged the challenges facing many providers across the country due to recent natural disasters and the Delta variant, HHS announced a final 60-day grace period to help providers come into compliance with their PRF Reporting requirements if they fail to meet the deadline on September 30, 2021. While the deadlines to use funds and the Reporting Time Period will not change, HHS will not initiate collection activities or similar enforcement actions for non-compliant providers during this grace period.

Members can access more information about eligibility requirements, the documents and information providers will need to complete their application, and the application process for PRF Phase 4 and ARP Rural payments by visiting the HRSA website.

The combined application for American Rescue Plan rural funding and Provider Relief Fund Phase 4 will open on September 29, 2021.  Like we have done with the previous rounds of HHS funding, we encourage all ambulance service providers to submit an application for this Phase 4 funding.  If you have questions regarding this or any COVID-19 related questions, please contact hello@ambulance.org.

Biden Issues Exec Orders Requiring COVID-19 Vaccinations

The Biden Administration Issues Several Executive Orders Requiring Mandatory COVID-19 Vaccination

On September 9, 2021, the Biden Administration issued several Executive Orders which impact more than 100 million workers in an effort to end the COVID-19 pandemic.  The two Executive Orders, Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees and Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors were highlighted during a Presidential press conference.

During his announcement, President Biden said that there are more than 80 million Americans, who are not vaccinated.  As a result he stated that “it is essential that Federal employees take all available steps to protect themselves and avoid spreading COVID-19 to their co-workers and members of the public.”  Additionally, the President stated he issued these orders “to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law.”

The orders will require that all Federal employees and employees of Federal Contractors mandate vaccination.  The President stated that if businesses and individuals want to work with the federal government, they must be vaccinated.  Under the order, The Safer Federal Workforce Task Force (Task Force), will issue guidance to all covered agencies consistent with these Orders within seven (7) days.

The President also announced that the U.S. Department of Labor (U.S. DOL) will be issuing emergency rules that will require employers of 100 or more employees to require vaccination or mandatory weekly COVID-19 testing for all workers.  Additionally, the President announced that he is expanding requirements for employers to provide paid leave to employees so that they can obtain the COVID-19 vaccinations.  He provided no details on how much the paid leave requirement will be expanded.

Lastly, the Centers for Medicare and Medicaid Services (CMS) announced that it will be expanding the vaccination requirements for healthcare facilities that bill Medicare.  Currently, the Biden Administration requires that all long-term care staff working for facilities that bill Medicare must be vaccinated against COVID-19.  In the latest announcement, CMS stated that it will be expanding the mandatory vaccination requirements to other Medicare-certified facilities, including hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, and others, as a condition for participating in the Medicare and Medicaid programs.  CMS is developing an Interim Final Rule with Comment Period that will be issued sometime in October.

The President’s expanded COVID-19 plan follows numerous states, such as Connecticut, Rhode Island, California, Massachusetts, and several others that have already enacted mandatory vaccination requirements for healthcare, county or municipal, and long-term care workers.  Many of states that have enacted mandatory vaccination requirements provided for no vaccination exceptions, or made provisions for medical exceptions to the vaccination requirements.

We will not know the specific vaccine mandate requirements under these new rules until the Task Force, the U.S. DOL, and CMS publishes these emergency rules.  It is important for employers to understand that they are still required to engage any employee seeking an accommodation from the mandatory vaccination requirements in the interactive process as required under the Americans with Disabilities Act (ADA) or Title VII of the Civil Rights Act.  We recommend employers follow a consistent documented process and seek legal advice when handling any accommodation requests.

We will continue to monitor developments with these new requirements.  Be sure to contact the AAA if you have questions about these Executive Orders or need assistance in ensuring you are in compliance.